Thousands of Artificial Knees and Hips Wear Out Prematurely

By Fred Schulte, KFF Health News

Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.

Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants.

Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.

RON IRBY

Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”

A KFF Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.

In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”

“I think they were cutting corners to improve their bottom line,” Irby told KFF Health News.

Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”

‘Trailblazing’ Implant

Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.

Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.

Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.

Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company.

Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.

Optetrak knee implant

Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”

Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.

“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.

“There was no disclosure or transparency.”

Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”

Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.

‘Popping Out Right and Left’

In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.

One knee implant gave out in just nine months, Moody told the group, according to the minutes.

In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.

Moody “probably had 50-something revisions. … They’re just popping out right and left,” the sales agent said, according to Farley’s suit.

Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.

Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.

The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.

Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.

Late Reporting to FDA

The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.

Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.

KFF Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.

FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.

In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.

The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.

The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.

Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.

Cutting Corners

In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.

Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities.”

Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.

His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.

Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.

In advertising directed at surgeons, Exactech boasts about the long life of its implants.

One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.

The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.

The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.

Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.

How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.

Consulting Fees

Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.

Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.

In promoting the Optetrak in sales materials, Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.

Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”

Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.

One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”

A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.

The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.

The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.

James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.

In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”

‘Dear Patient’

Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.

Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.

Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.

In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.

Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.

Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.

In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.

Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.

In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.

But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.

In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.

Total Recall

Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.

Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”

Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.

In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.

The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An FDA “safety communication” issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.

Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.

In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.

“So every case is different,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Hospitals Hit Hard by Loss of Joint Replacement Surgeries

By Bernard J. Wolfson, Kaiser Health News

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

Billions in Revenue Lost

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

‘Industrial-Scale’ Surgeries

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“Generally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

After canceling his hip replacement surgery in March because of COVID-19, Matthew Davis overcame his concerns and rescheduled in June because the procedure was performed at an outpatient surgery center, which meant no overnight hospital stay. (Matthew Davis)

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me — avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Joint Replacement Often Unnecessary

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem.

“I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

No Increase in Physical Activity after Hip Replacement

By Pat Anson, Editor

A new study by British researchers has come to the surprising conclusion that physical activity such as walking and climbing stairs does not increase after hip replacement surgery.

Total hip replacement is one of the most common elective procedures. The surgery is usually performed on the elderly to relieve pain from osteoarthritis, which causes a loss of cartilage and joint function.

But in the first systematic review to examine the differences in physical activity both before and after hip replacement, researchers were left questioning the purpose of the surgery.

"The most common reason for a hip replacement is to reduce pain on movement. We expected that the amount of physical activity post-surgery would therefore increase. What we found surprised us," said lead researcher Tom Withers, from the University of East Anglia’s School of Health Sciences.

Withers and his colleagues looked at the physical activity of over 1,000 patients who had hip replacements, analyzing how far and how fast they walked, as well as cycling and climbing stairs.

"We found that there was no clear evidence of a change in physical activity following surgery,” said Withers. "The benefits of regular physical activity following a hip replacement are well known, so this research is important for healthcare professionals because it suggests that patients need to be encouraged to be more physically active."

The research findings are being published in the journal Clinical Rehabilitation.

"The lack of significant difference in physical activity after patients undergo such a common procedure suggests there is a need for further research, including further investigation into how other personal characteristics or pre-existing conditions might also influence the results,” says Toby Smith, a lecturer in physiotherapy in UEA's School of Health Sciences.

"Healthcare professionals and researchers need to better understand this lack of change and how patient's perceptions of physical activity might be modified to increase their engagement in physical activity post-operatively."

Recent studies in the United States have questioned whether many joint replacement surgeries are appropriate. A five year study of 175 knee replacement patients by the National Institutes of Health found that over a third of the surgeries were inappropriate. Many patients had pain and other symptoms that were too mild to justify having their knees replaced.  

About 30 million Americans have osteoarthritis, including a growing number of younger patients, aged 40 to 65. Doctors are often reluctant to perform hip replacement surgery on patients under age 50 because prosthetic joints typically last for less than 20 years. A second surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection and other complications.

Stem Cell Therapy Could Avoid Joint Replacement

By Pat Anson, Editor

An experimental stem cell treatment that grows new cartilage could someday help millions of arthritis patients avoid joint replacement surgery.

Researchers at Washington University School of Medicine in St. Louis and Cytex Therapeutics in Durham, N.C. have developed a 3-D, biodegradable synthetic scaffold that is molded into the precise shape of a patient’s hip joint.

The scaffold, which is covered with cartilage made from the patient’s own stem cells, is designed to be implanted onto the surface of an arthritic hip.

Resurfacing the hip joint with this “living” tissue could ease arthritis pain, and may delay or even eliminate the need for hip replacement surgery, according to researchers.

Joint replacement surgery is usually performed on the elderly to relieve pain from osteoarthritis, a painful and disabling condition caused by a loss of cartilage and the degradation of joints. Over a million hip and knee joint replacement surgeries are performed annually – a number expected to surpass four million by 2030 due to the aging of the U.S. population. 

WASHINGTON UNIVERSITY IMAGE

“We’ve developed a way to resurface an arthritic joint using a patient’s own stem cells to grow new cartilage, combined with gene therapy to release anti-inflammatory molecules to keep arthritis at bay. Our hope is to prevent, or at least delay, a standard metal and plastic prosthetic joint replacement,” said Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University.

After inserting a gene into the newly grown cartilage and activating it with a drug, researchers say the gene will release anti-inflammatory molecules to fight arthritis.

“When there is inflammation, we can give a patient a simple drug, which activates the gene we’ve implanted, to lower inflammation in the joint,” said Guilak. “We can stop giving the drug at any time, which turns off the gene.”

By adding gene therapy to the stem cell and scaffold technique, Guilak and his colleagues believe it will be possible to coax patients’ joints to fend off arthritis, preserve cartilage, and function better for a longer time.

The 3-D scaffold is built using a weaving pattern that gives the device the structure and properties of normal cartilage. It is made with hundreds of biodegradable fiber bundles that are woven together to create a high-performance fabric that functions like normal cartilage.

“The woven implants are strong enough to withstand loads up to 10 times a patient’s body weight, which is typically what our joints must bear when we exercise,” said Franklin Moutos, PhD, vice president of technology development at Cytex.

Scientists have tested the tissue engineering in cell culture, and some customized implants are being tested in laboratory animals. If all goes well, such devices could be ready for testing in humans in three to five years.

Currently, there are about 30 million Americans who have osteoarthritis. That number includes a growing number of younger patients — ages 40 to 65 — who have limited treatment options.  Doctors are often reluctant to perform hip replacement surgery on patients under age 50 because prosthetic joints typically last for less than 20 years. A second surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection and other complications.

“We envision in the future that this population of younger patients may be ideal candidates for this type of biological joint replacement,” said Bradley Estes, PhD, vice president of research and development at Cytex.

The research findings, which are published in the Proceedings of the National Academy of Sciences, are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging, which are both part of the National Institutes of Health (NIH).

Hospitals Accountable for Joint Replacement Surgeries

By Pat Anson, Editor

Hospitals will be held accountable for the cost and quality of care given to Medicare patients who undergo hip and knee replacement surgery under a pilot program by the Center for Medicare and Medicaid Services (CMS).

Hip and knee replacements are the most common inpatient surgery for Medicare beneficiaries. In 2014, there were more than 400,000 such procedures, costing Medicare more than $7 billion for hospitalizations alone. Post-surgery complications such as pain and infection often lead to hospital readmissions and extended recovery periods.

Under the Comprehensive Care for Joint Replacement (CJR) model, the hospital where the surgery takes place will be accountable for all services from the time of the surgery through 90 days after hospital discharge. This “bundling” of payments for hospitals, physicians, physical therapists and other health providers is meant to encourage them to work together to deliver more effective and efficient care.

Depending on the hospital’s quality and cost performance, the hospital will either earn a financial reward or be required to refund Medicare for a portion of the cost.

The quality and cost of care for hip and knee replacement surgeries can vary greatly. Currently the average Medicare expenditure for surgery, hospitalization, and recovery ranges from $16,500 to $33,000 across geographic areas. The rate of complications from infections or implant failures can be more than three times higher at some facilities than others.

“Incentives to coordinate the whole episode of care – from surgery to recovery – are not strong enough, and a patient’s health may suffer as a result,” CMS said in a statement. “When approaching care without seeing the big picture, there is a risk of missing crucial information or not coordinating across different care settings. This approach leads to more complications after surgery, higher readmission rates, protracted rehabilitative care, and variable costs. These are not the health outcomes patients want.”

The CJR model is being tested in 67 metropolitan areas throughout the country, and nearly all hospitals in those areas are required to participate. Patients will still be able to choose their doctor, hospital, nursing facility, home health service, and other providers. A list of all 67 areas can be found here.

The aging of the U.S. population is causing a surge in hip and knee replacement surgeries. Over a million joint replacement surgeries are currently performed annually – a number expected to surpass four million by 2030. 

Joint replacement surgery is generally conducted on the elderly to relieve pain from osteoarthritis, a painful and disabling condition caused by a loss of cartilage and the degradation of joints. Twenty-seven million Americans suffer from osteoarthritis.

Recent studies have questioned whether many of the surgeries are appropriate. A five year study of 175 knee replacement patients by the National Institutes of Health found that over a third of the surgeries were inappropriate, according to researchers who found that many patients had pain and other symptoms that were too mild to justify having their knees replaced.  Less than half (44%) of the knee replacement surgeries were classified as appropriate, with 22% rated inconclusive and 34% deemed inappropriate.

Racial Disparities Found in Joint Replacement Surgery

By Pat Anson, Editor

Black, Hispanic and Medicaid patients are significantly more likely to be readmitted to the hospital after total joint replacement (TJR) surgery, while women are less likely to suffer complications, according to new studies presented at the annual meeting of the American Academy of Orthopaedic Surgeons in Las Vegas.

In one study, researchers analyzed race and ethnic data on nearly 53,000 patients admitted to Connecticut hospitals for TJR from 2008 to 2012. The average patient was 67 years of age, white, female and covered by Medicare.

Patients who were African-American were 62% more likely to be readmitted to the hospital within 30 days of TJR. Hispanic patients were 50% more likely and Medicaid patients were 40% more likely to be readmitted than patients with private insurance.

"Our study shows that black patients who undergo total knee replacement may have poorer outcomes," said lead study author and orthopedic surgeon Courtland Lewis, MD. "After controlling for two key variables implicated in race and ethnic disparities in hospital readmission -- preoperative comorbidities and type of insurance coverage -- black patients still have a 35 percent higher likelihood of all-cause, 30-day readmission compared to white patients.”

Lewis said the disparity with white patients may be due to black patients having less access to primary care and less communication with health care providers.

Racial disparities in health care have long been documented, including that black patients utilize hip and total knee replacement at rates nearly 40 percent less than white patients, despite having higher rates of osteoarthritis—a leading cause of joint deterioration. Total hip and knee replacements are common surgical treatments for late-stage arthritis.

The overall 30-day readmission rate for patients in the study was about 5 percent. The most common reasons for readmission were postoperative infection, inflammatory reaction due to a joint prosthesis, hematoma complications, and dislocation of a prosthetic joint.

A second study looked at nearly 60,000 knee and hip replacements at a hospital in Ontario, Canada. Researchers found that men were 15% likely than women to return to the emergency department within 30 days of TJR surgery – even though women who had the surgery were older and more likely to be frail. Over half the patients in the study were women.

The findings contradict the theory that TJR is underutilized in female patients because they have worse outcomes then men.

"Despite the fact that women have a higher prevalence of advanced hip and knee arthritis, prior research indicates that North American women with arthritis are less likely to receive joint replacement than men," said lead study author Bheeshma Ravi, MD, an orthopaedic surgery resident at the University of Toronto. "One possible explanation is that women are less often offered or accept surgery because their risk of serious complications following surgery is greater than that of men.

"In this study, we found that while overall rates of serious complications were low for both groups, they were lower for women than for men for both hip and knee replacement, particularly the latter" said Dr. Ravi. "Thus, the previously documented sex difference utilization of TJR cannot be explained by differential risks of complications following surgery." 

Men in the study were found to be up 70 percent more likely to have a heart attack within three months of TJR surgery and 70 percent more likely to have an infection or require revision surgery within two years of a total knee replacement.